Table 1.
Limits for carbohydrate impurities in Lactulose formulations according to monographs in the European Pharmacopoeia
Lactulose crystals | Lactulose liquid1 | |
Epilactose | ≤ 0.5% | ≤ 10.0% |
Galactose | ≤ 0.5% | ≤ 15.0% |
Lactose | ≤ 3.0% | ≤ 10.0% |
Fructose | ≤ 0.5% | ≤ 1.0% |
Tagatose | ≤ 0.5% | ≤ 4.0% |
3-Deoxy-D-glyceropentulose | - | ≤ 4.0% |
Total impurities | ≤ 3.0% | ≤ 12.0% (excluding galactose and lactose) |
Values relative to lactulose.